211^At-BC8-B10 Before Donor Stem Cell Transplant in Treating Patients With High-Risk Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Myelodysplastic Syndrome, or Mixed-Phenotype Acute Leukemia

Part of paid clinical trials in Seattle, Washington.

Sponsor
Fred Hutchinson Cancer Center
Study ID
NCT03128034
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Acute Lymphoblastic Leukemia
  • Acute Myeloid Leukemia
  • Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
  • Chronic Myelomonocytic Leukemia
  • Mixed Phenotype Acute Leukemia
  • Myelodysplastic Syndrome With Excess Blasts
  • Recurrent Acute Lymphoblastic Leukemia
  • Recurrent Acute Myeloid Leukemia
  • Recurrent Mixed Phenotype Acute Leukemia
  • Refractory Acute Lymphoblastic Leukemia
  • Refractory Acute Myeloid Leukemia
  • Refractory Mixed Phenotype Acute Leukemia

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Cyclosporine — DRUG
    Given PO or IV
  • Fludarabine Phosphate — DRUG
    Given IV
  • Mycophenolate Mofetil — DRUG
    Given PO or IV
  • Peripheral Blood Stem Cell Transplantation — PROCEDURE
    Undergo allogeneic PBSC transplant
  • Pretargeted Radioimmunotherapy — RADIATION
    Given 211\^At-BC8-B10 IV
  • Total-Body Irradiation — RADIATION
    Undergo TBI
  • Pretargeted Radioimmunotherapy — RADIATION
    Given 131\^I-BC8-B10 IV
  • Biospecimen Collection — PROCEDURE
    Undergo blood and bone marrow aspirate sample collection
  • Single Photon Emission Computed Tomography — PROCEDURE
    Undergo SPECT

Study Details

This phase I/II trial studies the side effects and best dose of 211\^astatine(At)-BC8-B10 before donor stem cell transplant in treating patients with high-risk acute myeloid leukemia, acute lymphoblastic leukemia, myelodysplastic syndrome, or mixed-phenotype acute leukemia. Radioactive substances, such as astatine-211, linked to monoclonal antibodies, such as BC8, can bind to cancer cells and give off radiation which may help kill cancer cells and have less of an effect on healthy cells before donor stem cell transplant.

Key Dates

Start date
Oct 24, 2017
Status verified
Dec 2025
Primary completion
Jun 30, 2027
Completion
Mar 31, 2029

Study Design

Enrollment
75 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (211^At-BC8-B10, PBSC)
    Patients receive 211\^At-BC8-B10 IV over 6-8 hours on day -7 and may receive 131\^I-BC8-B10 IV on day -7 and fludarabine phosphate IV over 30 minutes on days -4, -3 and -2. Patients undergo TBI and PBSC transplant on day 0. Patients also receive cyclosporine PO or IV every 12 hours on days -3 to 56 and then tapered to day 180, or continuing to day 96 and then tapered to day 150. Patients receive mycophenolate mofetil PO or IV (first dose to occur 4-6 hours after PBSC infusion) every 12 hours on days 0-27 (for patients with related donors) or every 8 hours on day 0 and then reduced to every 12 hours on days 30-150 then tapered to day 180 (for patients with unrelated donors). Patients may undergo SPECT, bone marrow aspirate sample and blood sample collection on study.

Primary Outcome Measure

Incidence of grades III/IV Bearman regimen-related toxicity [ Time Frame: Up to 100 days following hematopoietic cell transplantation ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Fred Hutch/University of Washington Cancer ConsortiumSeattleWashington98109
Brenda M. Sandmaier
[email protected]
206-667-4961
Brenda M. Sandmaier (PRINCIPAL_INVESTIGATOR)

Find similar trials in Seattle, WA

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
Fred Hutch/University of Washington Cancer Consortium· Seattle, WA

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